RESPONSIBILITIES

- Ensure final submission of the dossier in Brazil; Latin America; Europe and ROW (Rest of World) market in line with current guidance and achieved within the timeline.
- Handle queries from agencies and customers and variations of technical agreements etc.
- Facilitate and ensure life cycle management activity as per current guidance.
- Coordinate with departments such as ACASIA, FDA, FD, medical, commercial, packaging development, project management & manufacturing location such as QA, QC, production, etc.
- Review technical documents such as MPRs, specifications, COAs, process validations, method validations, stability, etc. to ensure minimum queries on these parts of the dossier.
- Approve packaging documents such as specifications, standard test procedures, etc.
- Interact with agents, distributors, customers, consultants etc. for new registration and life cycle management of registered products.
- Update & maintain registration database, product & company registration status, monthly report, capex, and budget.




- Handle the EMS system for export order forwarding & update the registration status.
- Organize and monitor departmental SOP training.
- Monitor administrative job responsibility.
- Monitor DCGI submission for new drug applications.
- Monitor the performance of sub-ordinates.

Desired Skills

- Should have strong experience in handling regulatory submissions for Brazil, Latin America and ROW
- Should have strong experience in regulatory inspections.
- Should have team handling experience.
- Knowledge of compliance must be strong.
- Proactive approach to queries, with solid problem-solving, decision-making, and communication skills.
- Ability to manage multiple stakeholders, lead teams, and work effectively across functions.
- High standards of business ethics, integrity, confidentiality, attention to detail, and compliance.
- Should be willing to work in dynamic environment.

📌 Associate General Manager - Regulatory Affairs (Mumbai)
🏢 Unichem Laboratories
📍 Mumbai